SKB315 in Combination Therapy in Patients With Advanced or Metastatic GC/ GEJ Adenocarcinoma

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

About this trial

This study is a multicenter,open-label,randomized, phase II clinical study conducted in China. The purpose of this study is to evaluate the efficacy of SKB315 plus PD-1 inhibitor ±capecitabine in patients with Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility criteria

Qualifiers

Locally advanced unresectable or metastatic gastric cancer (GC) or gastroesophageal junction (GEJ) carcinoma and have histologically confirmed adenocarcinoma

No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer.

Consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment, and advanced solid tumors with Claudin 18.2 and PD-L1 expression as determined by IHC;

Presence of at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

Disqualifiers

Active leptomeningeal disease or uncontrolled brain metastasis

Diagnosed with gastric or GEJ adenocarcinoma with positive HER2

Received other drugs in clinical study, major surgeries, or any other antitumor therapies within 4 weeks prior to the first dose of study treatment;

Patients with active hepatitis B or hepatitis C;

Trial design

Treatments tested in this trial

  • Tislelizumab
  • SKB315 for injection
  • Capecitabine

Treatment groups

80 Participants
are divided into 2 treatment groups